Recall Z-1499-2017— Stanley Security Solutions Inc
Class II · Terminated
Class II FDA medical device recall by Stanley Security Solutions Inc, initiated 2016-06-22, terminated 2017-11-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part of the Arial wireless emergency call management system. It enables residents in assisted living, skilled nursing or independent living to call staff with the press of a button.. Reason: Devices were incorrectly programmed during manufacturing therefore depressing the pendant button may result in an alarm not sounding as intended..
- Recalling firm
- Stanley Security Solutions Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-06-22
- Terminated
- 2017-11-20
- Firm location
- Lincoln, NE, United States
Product description
Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part of the Arial wireless emergency call management system. It enables residents in assisted living, skilled nursing or independent living to call staff with the press of a button.
Reason for recall
Devices were incorrectly programmed during manufacturing therefore depressing the pendant button may result in an alarm not sounding as intended.
Data sourced from openFDA. This site is unofficial and independent of the FDA.